| Methods |
Randomisation/allocation method unclear. Double‐blind, parallel trial
30 women randomised and analysed
Method of assessing adverse effects: self reported prospectively on chart |
| Participants |
Inclusion: primary dysmenorrhoea for at least 6 months of medium‐high gravity; regular menstrual cycles; nulliparous
Exclusion: light menstrual upsets or irregularities, organic dysmenorrhoea, IUD or OCP use, allergies to NSAIDs, gastrointestinal problems
Age: 15 to 25, mean 23.8 (2.6)
Location: Italy |
| Interventions |
Meclofenamate sodium 100 mg, naproxen sodium 275 mg
Taken at first sign of menses, then every 8 hours
Duration: 1 control cycle, then 5 treatment cycles |
| Outcomes |
Pain assessment ‐ VAS (graph)
Dysmenorrhoea symptoms |
| Notes |
No mention of baseline comparison. No numerical data reported for adverse effects |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not described |
| Allocation concealment (selection bias) |
Unclear risk |
Method not described |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, placebo not described |
| Selective reporting (reporting bias) |
Low risk |
Women prospectively asked to record adverse effects |
| Complete follow‐up? |
Low risk |
30/30 women analysed |
| Potential bias related to study funding |
Unclear risk |
Not stated |
